FUMARAN 240 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Dimethyl Fumarate Adamed, 120 mg, Gastro-Resistant Capsules, Hard
3. Dimethyl Fumarate Adamed, 240 mg, Gastro-Resistant Capsules, Hard
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Dimethyl Fumarate Adamed and what is it used for
   1. What is Dimethyl Fumarate Adamed
   2. What is Dimethyl Fumarate Adamed used for
   3. Dimethyl Fumarate Adamed is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
   4. How does Dimethyl Fumarate Adamed work
   5. Dimethyl Fumarate Adamed appears to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.
5. Important information before taking Dimethyl Fumarate Adamed
   1. When not to take Dimethyl Fumarate Adamed:
   2. Warnings and precautions
   3. Children and adolescents
   4. Dimethyl Fumarate Adamed and other medicines
   5. Dimethyl Fumarate Adamed with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Dimethyl Fumarate Adamed contains sodium
6. How to take Dimethyl Fumarate Adamed
   1. Initial dose
   2. 120 mg twice a day.
   3. Usual dose
   4. 240 mg twice a day.
   5. Taking more Dimethyl Fumarate Adamed than prescribed
   6. Missing a dose of Dimethyl Fumarate Adamed
7. Possible side effects
   1. Severe side effects
   2. If you experience any of the following symptoms, contact your doctor immediately
   3. Severe allergic reactions
   4. Stop taking Dimethyl Fumarate Adamed and contact your doctor immediately
   5. Very common side effects:
   6. Common side effects
   7. Uncommon side effects
   8. Frequency not known
   9. Children (aged 13 and over) and adolescents
   10. Reporting side effects
8. How to store Dimethyl Fumarate Adamed
9. Contents of the pack and other information
   1. What Dimethyl Fumarate Adamed contains
   2. What Dimethyl Fumarate Adamed looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet: 04.2024

Package Leaflet: Information for the Patient

Dimethyl Fumarate Adamed, 120 mg, Gastro-Resistant Capsules, Hard

Dimethyl Fumarate Adamed, 240 mg, Gastro-Resistant Capsules, Hard

Dimethyl Fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dimethyl Fumarate Adamed and what is it used for
• 2. Important information before taking Dimethyl Fumarate Adamed
• 3. How to take Dimethyl Fumarate Adamed
• 4. Possible side effects
• 5. How to store Dimethyl Fumarate Adamed
• 6. Contents of the pack and other information

1. What is Dimethyl Fumarate Adamed and what is it used for

What is Dimethyl Fumarate Adamed

Dimethyl Fumarate Adamed is a medicine that contains dimethyl fumarate.

What is Dimethyl Fumarate Adamed used for

Dimethyl Fumarate Adamed is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord. The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of neurological symptoms (relapses). Symptoms vary among patients but usually include problems with walking and balance, and vision disturbances (e.g., blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How does Dimethyl Fumarate Adamed work

Dimethyl Fumarate Adamed appears to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimethyl Fumarate Adamed

When not to take Dimethyl Fumarate Adamed:

• If you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• If you suspect or have been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl Fumarate Adamed may affect your white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Adamed, your doctor will check your white blood cell count and ensure that your kidneys and liver are working properly. These tests will be performed periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop the treatment.

Before taking Dimethyl Fumarate Adamed, discuss with your doctorif you have:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection(e.g., pneumonia)

During treatment with Dimethyl Fumarate Adamed, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect any symptoms of shingles, inform your doctor immediately. If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or you develop new symptoms, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.

Children and adolescents

The above warnings and precautions also apply to children. Dimethyl Fumarate Adamed can be used in children and adolescents aged 13 years and older. Data on children under 10 years of age are not available.

Dimethyl Fumarate Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the immune system, including other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomid, alemtuzumab, ocrelizumab, or cladribine, and some medicines commonly used to treat cancer (rituximab or mitoxantrone);
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and similar anti-inflammatory medicines, as well as over-the-counter medicines), and medicines containing lithium;
• the use of certain vaccines (live vaccines)

During treatment with Dimethyl Fumarate Adamed, the use of live vaccines may lead to infection, so it should be avoided. Your doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Dimethyl Fumarate Adamed with food and drink

Avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) in amounts greater than 50 ml within an hour of taking Dimethyl Fumarate Adamed, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Dimethyl Fumarate Adamed should not be taken during pregnancy unless you have discussed it with your doctor.

Breastfeeding

It is not known whether the active substance of Dimethyl Fumarate Adamed passes into human milk. Dimethyl Fumarate Adamed should not be taken during breastfeeding. Your doctor will help you decide whether to stop breastfeeding or stop taking Dimethyl Fumarate Adamed, based on the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

The effect of Dimethyl Fumarate Adamed on the ability to drive and use machines is not known.

It is not expected that Dimethyl Fumarate Adamed will affect your ability to drive and use machines.

Dimethyl Fumarate Adamed contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Dimethyl Fumarate Adamed

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Initial dose

120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the usual dose should be taken.

Usual dose

240 mg twice a day.

Dimethyl Fumarate Adamed should be taken orally.

Each capsule should be swallowed whole, with water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.

Dimethyl Fumarate Adamed should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking more Dimethyl Fumarate Adamed than prescribed

If you have taken more capsules than prescribed, inform your doctor immediately. Side effects may occur, similar to those described below in section 4.

Missing a dose of Dimethyl Fumarate Adamed

Do not take a double doseto make up for a missed dose.

A missed dose can be taken if it is within 4 hours before the next dose. If it is too late, do not take the missed dose. In any case, take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl Fumarate Adamed can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl Fumarate Adamed may decrease the number of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should monitor your white blood cell count throughout treatment, and you should be aware of symptoms that may indicate PML.

The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML may resemble a relapse of multiple sclerosis. They include weakness or increased weakness on one side of the body, coordination problems, vision disturbances, problems with thinking or memory, confusion (disorientation), or personality changes, speech problems, and communication difficulties lasting more than a few days. Therefore, if you experience worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl Fumarate Adamed, you should contact your doctor immediately. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You may not be aware of some symptoms.

If you experience any of the following symptoms, contact your doctor immediately

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown).

A very common side effect is sudden (flushing) redness of the skin on the face or body. If flushing is accompanied by a red rash or hives andany of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema);
• wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia);
• dizziness or loss of consciousness (hypotension), it may indicate a severe allergic reaction (anaphylaxis).

Stop taking Dimethyl Fumarate Adamed and contact your doctor immediately

Very common side effects:

These symptoms may occur in more than 1 in 10 people:

• redness of the skin on the face or a feeling of increased body temperature, heat, burning of the skin, or itching of the skin (flushing)
• diarrhea
• nausea
• stomach pain or cramps
• Taking the medicine with foodwill help alleviate the above side effects

During treatment with Dimethyl Fumarate Adamed, ketone bodies (substances normally produced in the body) are very commonly found in urine tests.

Ask your doctorhow to deal with side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor advises you to do so.

Common side effects

These symptoms may occur in up to 1 in 10 people, but not more often:

• inflammation of the lining of the intestines (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes, feeling of heat
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may affect laboratory test results

• low white blood cell count (lymphopenia, leukopenia). A decreased white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (e.g., pneumonia), contact your doctor immediately;
• protein (albumin) in the urine;
• increased liver enzyme activity (ALT, AST) in the blood.

Uncommon side effects

These symptoms may occur in up to 1 in 100 people, but not more often:

• allergic reactions (hypersensitivity)
• decreased platelet count

Frequency not known

(frequency cannot be estimated from the available data)

• liver inflammation and increased liver enzyme activity (ALT or AST together with bilirubin)
• shingles, with symptoms such as blisters on the skin, burning, itching, or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, itching, or red spots and severe pain
• common cold (rhinitis)

Children (aged 13 and over) and adolescents

The above side effects also apply to children. Some side effects have been reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimethyl Fumarate Adamed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after "EXP".

The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate Adamed contains

The active substance is dimethyl fumarate.

Dimethyl Fumarate Adamed, 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Adamed, 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredientsare:

Capsule contents (gastro-resistant mini-tablets): microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion

Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172).

Capsule printing ink (black): shellac (20% esterified), propylene glycol (E1520), black iron oxide (E172).

What Dimethyl Fumarate Adamed looks like and contents of the pack

Dimethyl Fumarate Adamed, 120 mg: gastro-resistant capsules, hard, with a white, opaque body and light green, opaque cap, with "120" printed in black ink on the body, containing mini-tablets.

Dimethyl Fumarate Adamed, 240 mg: gastro-resistant capsules, hard, with a light green, opaque body and light green, opaque cap, with "240" printed in black ink on the body, containing mini-tablets.

Package sizes:

Gastro-resistant capsules, hard, 120 mg: 14 capsules.

Gastro-resistant capsules, hard, 240 mg: 56 or 168 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

tel. 22 732 77 00

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 04.2024